°Ç¸ç³Ô¹Ï

Skip to main content
Guidance

Getting the most from your ISA meeting

Updated 16 March 2026

Companies requesting Integrated Scientific Advice will have a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) andÌýNational Institute for Health and Care ExcellenceÌý(NICE). This the chance to present the project and get answers to specific questions.

MeetingsÌýareÌýplanned for up toÌý2Ìýhours.ÌýÌýÌý

Preparing for the meeting

ÌýTheÌýcompany presentation should be concise. You will need to discuss all agenda items and questions in the briefing bookÌýwithin theÌýallocatedÌýtime.

Providing background information

You will have up to 20 minutes at the start of the advice meeting to present background information on the technology (typically 4 slides). This is limited to: Ìý

  • the claimedÌýindication

  • the value proposition

  • the status of development

  • the proposed position in the NHS treatment pathway

  • aÌýshort summaryÌýof company’s development plans

  • any significant updates since the briefing book was produced

Provide a table of the relevant studies

You should present the studies that are the subject of the scientific advice in a tableÌýsummarising their main aspects, including: Ìý

  • overall design

  • ±è°ù¾±³¾²¹°ù²âÌý´Ç²úÂá±ð³¦³Ù¾±±¹±ðÌý

  • population and sample size

  • comparators

  • primary and secondary endpoints

  • quality-of-life measures

Detail changes since the briefing book

If relevant, include slides highlighting any changes to the development programme since the briefing book was produced. This section should typically be 4 slides.   Ìý

Focus the main presentation on questions and issues

The rest of the presentation should focus on the questions included in the briefing book with a summary of the company’s position (1 to 2 slides per question).Ìý

When factoring in NICE and the MHRA’s list of issues, it is helpful toÌýconsolidateÌýthe responses to the issues under relevant headings such as population, comparators,ÌýendpointsÌýandÌýhealth economic modelling.Ìý

If patient experts are involved, the company is encouraged to present 1 slide discussing patient involvement and patient experience with the disease and technology.Ìý

The company is also encouraged to present and discuss NHS implementation issues, if any.Ìý

Timings, extra slides and providing information in advance

AdditionalÌýslides can be included as back-up slides (for example, results from early phase studies, relevant extracts from clinical guidelines or treatment pathways, selected bibliography).  Ìý

The total number of slides should support a productive discussion during the meeting (typically aÌý3-hour meeting should notÌýcontainÌýmore than 24 slides).Ìý

The company should sendÌýNICEÌýand the MHRAÌýits slidesÌýwith theÌýagenda.ÌýUse the format of Figure 1 to provide the list ofÌýdiscussion areas.ÌýA 10-minute breakÌýshouldÌýbeÌýfactored into the meeting around the halfway point,Ìýso the total amount of timeÌýallocatedÌýfor discussion points will beÌý2ÌýhoursÌý20 minutes.

Figure 1 example meeting agenda

Agenda item Time
Welcome and introductions XX:00
Presentation by company XX:10
Discussion points (and timeÌýallocatedÌýto each): Ìý
Discussion point 1 XX:XX
Discussion point 2 … XX:XX
Break (10mins) Ìý
Discussion point … 3 XX:XX
Discussion point 4 Ìý
Meeting close Ìý

Further information and how to get in touch

Further information

See detailed guidance on Integrated Scientific Advice

See supplementary information on the ISA service

Contact details

Email scientific_advice@mhra.gov.uk